Connect with us

National

Clarifications From Bharat Biotech On Covaxin Likely By Weekend: WHO – dot newz

Published

on


Expect to receive clarifications from Bharat Biotech by end of this week: WHO (Representational)

United Nations/Geneva:

The World Health Organisation on Wednesday said it expects to receive clarifications from Bharat Biotech by the end of this week on its COVID-19 vaccine — Covaxin — and will meet on November 3 for a final risk-benefit assessment for the Emergency Use Listing.

“WHO Technical Advisory Group for Emergency Use Listing (EUL) is an independent advisory group that provides recommendations to WHO on whether a #COVID19 vaccine can be listed for emergency use under the EUL procedure,” the WHO tweeted.

The Technical Advisory Group met October 26 and “decided that additional clarifications from the manufacturer (Bharat Biotech) are needed to conduct a final EUL risk-benefit assessment for global use of the Covaxin vaccine”.

“The Technical Advisory Group expects to receive these clarifications from the manufacturer (Bharat Biotech) by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, November 3, 2021,” the WHO tweeted.

The global health body also tweeted a video of WHO Health Emergencies Programme Executive Director Dr Mike Ryan, who said the World Health Organisation “is very clear that we want all countries to recognize EUL vaccines that have been given an Emergency Use Listing (EUL) by the WHO advisory process. But it”s also very important that WHO, when it makes a recommendation like that, is making that globally.”

Ryan had said “we have to be absolutely sure” and it’s really important that “we gather all of the necessary information not only on the vaccine itself but on the manufacturing processes and all of that, because we’re recommending to the world that this vaccine is safe, effective and it’s been produced using the highest quality standards”.

Further explaining how the WHO technical advisory group works, he said the vaccine manufacturers first of all have to request and respond and say that they want their vaccines to be put for EUL and then provide documentation on the whole process – the efficacy studies and the manufacturing process.

“Sometimes that requires visits to look at and examine the manufacturing practices and all of that has to come together into a dossier that’s presented within this advisory group mechanism, and then it’s from there that WHO can make a recommendation,” he said.

Ryan emphasised that the entire process, even if people cannot see it “day to day”, is “very measured” because “we’re having to say to the world ‘we’ve looked at this carefully, we’ve looked at every piece of data, we’ve looked at the whole production cycle and we can say with our hands on our hearts, having looked at all that data, here is a safe, effective, and well-produced product that you as our member state or you as a citizen of the world can take with confidence”.

“That’s very, very important and that sometimes takes longer and it is frustrating. And it is particularly frustrating if you’ve had a certain vaccine that is not recognised by another country and you can’t travel. That becomes an issue,” he said.

Ryan said the work done by the advisory group and its members has been of the highest quality, and “it takes time to do that.

“It’s a hugely important task. It’s extremely involved and measured, and the outputs of this process have been of very high quality right …through this pandemic. And if it takes another week or two, that’s what we’ll have to take to ensure that the dossier is complete to ensure that the committee have a chance to look at that and then WHO can make the right determination and give the right advice to the world.”

Ryan has added that the Emergency Committee of the International Health Regulations has been “very, very clear” and countries have been advised that vaccination certification should not be used as the only measure and means of restricting travel.

“We have other ways of making travel safe, including testing, serologic testing, and we very strongly believe that using vaccination status as the only parameter of travel creates a double inequity because countries who have no access to vaccines then by de facto have no access to travel either. And that’s a double inequity,” he has said.

In another video tweeted by WHO, Dr Mariangela Simao, Assistant Director General, Access to Medicines and Health Products at WHO, explained the process of emergency approvals of these vaccines and how safety is ensured in this process.

“It’s very important to highlight that no vaccine candidate should be used or issued an emergency approval at country level if it has not finished phase three trials because it’s during phase three trials that “you do the assessment of efficacy and safety”, she said in the video.

“When it comes to the assessment of the authority, it already has data on both efficacy and safety. The job is not finished yet because after this in order to authorise at country level, you need to assess whether the vaccine was ”well made”,” and complied with “good manufacturing practices and quality control,” Simao said.

“So this is to say that by the time it’s authorised at the country level, it has gone through a lot of scrutiny. So it’s very good to highlight that safety and efficacy will be guaranteed by the process that we have put in place,” she said.

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)





Source link

National

High Altitude Areas In Uttarakhand Receive Season’s First Snowfall – dot newz

Published

on

By


The sky remained overcast in the plains with isolated light showers at several places (File)

Dehradun:

The Himalayan temple of Kedarnath and the high altitude areas of Chamoli district received the season’s first snowfall on Thursday while it drizzled in the lower areas intensifying the chill across the state.

Besides the Kedarnath shrine in Rudraprayag district, the Musk Deer Park, Valley of Flowers and the Nanda Devi National Park in Chamoli district also received snowfall, officials in Dehradun said.

The sky remained overcast in the plains with isolated light showers at several places, including state capital Dehradun.

The temperature recorded in Dehradun on Thursday was 15.4 degrees Celsius, Tehri 10 degrees Celsius, Pantnagar 18.4 degrees Celsius, Mukteshwar 8.4 degrees Celsius and Almora 13.4 degrees Celsius, the MeT Department in Dehradun said.



Source link

Continue Reading

National

37 Years On, Bhopal Gas Tragedy Victims Still Await Adequate Compensation – dot newz

Published

on

By


“In 1984, Congress was in power in Madhya Pradesh and at Centre”: Bhopal Gas Tragedy Minister

Bhopal:

Thirty-seven years after the Bhopal gas tragedy, termed as the world’s worst industrial disaster, the survivors and the family of the dead are still waiting to be compensated fairly with an organisation working for them claiming that each victim has so far received less than one-fifth of the allotted sum.

The leak of methyl isocyanate, a toxic gas, from the pesticide plant of Union Carbide on the intervening night of December 2 and 3, 1984, had killed over 3,000 people and left 1.02 lakh others affected at that time. However, the number of affected later rose to over 5.70 lakh.

Talking to PTI, Madhya Pradesh’s Bhopal Gas Tragedy Relief and Rehabilitation Minister Vishvas Sarang said, “In 1984, the Congress was in power in Madhya Pradesh and at the Centre. The two governments did not put forth the case of the victims in a right manner to enable them to get more compensation.”

Bhopal Gas Peedith Sangharsh Sahayog Samiti (BGPSSS) co-convener ND Jayaprakash said the Supreme Court assisted settlement on February 14-15, 1989 worth Rs 705 crore was based on the assumption that only around 3,000 persons died and 1,02,000 were affected.

“This compensation was a complete sham as each gas victim ended up being given less than one-fifth of the sum allotted even as per the terms of that unjust settlement,” he added.

When asked to explain, he said that the financial aid was USD 470 million in 1989. The dollars turned into more than Rs 3,000 crore in 2004, when the disbursements started.

“But the number of the victims swelled to 5.73 lakh and this amount was distributed among them. So, each victim got one-fifth of the compensation,” he added.

“The failure on the part of the Supreme Court to hear the long-pending curative petition against the unjust settlement of 1989, has had an adverse impact on the interests of the gas victims,” he said in a media statement.

The curative petition (civil), which was filed by the Union of India on December 3, 2010 to challenge the unjust settlement of 1989 and to seek additional sum of at least another Rs 7,724 crore as compensation was last listed before the Constitution Bench of the Court on January 29 last year, he said.

“However, the hearing was postponed to February 11 last year. Sadly, the matter was never listed on that date or ever since then,” he said.

Failure to dispose of the curative petition has also meant the indefinite postponement of the hearing of the Special Leave Petition (SLP) filed on March 17, 2010 by eight members of Bhopal Gas Peedith Mahila Udyog Sangathan (BGPMUS) and BGPSSS, he said.

In the SLP, the two NGOs have sought enhancement of settlement sum by a factor of five in terms of the magnitude of the disaster as assessed by the claim courts and in terms of the gravity of injuries suffered by the gas victims on the basis of their medical records, Jayaprakash said.

Failure to dispose of the pending curative petition and the SLP for over a decade has effectively denied the gas-victims several thousands of crores of additional compensation that they are legitimately entitled to, he added.

In the curative petition, the Centre has sought Rs 7,724 crore as additional funds from successor firms of US-based Union Carbide Corporation, now owned by Dow Chemicals, for giving compensation to victims of the Bhopal gas tragedy.

The Centre, in its plea, is seeking a direction to Union Carbide and other firms for Rs 7,722 crore additional amount over and above the earlier settlement amount of USD 470 million in 1989 for paying compensation to the gas tragedy victims.

On June 7, 2010, a local court had convicted seven executives of Union Carbide India Limited (UCIL) to two years of imprisonment in connection with the incident. The then UCC chairman, Warren Anderson, was the prime accused in the case but did not appear for the trial. On February 1, 1992, the Bhopal CJM court had declared him an absconder. He died in the US in 2014. 



Source link

Continue Reading

National

5 Contacts Of Bengaluru Omicron Patient Test Positive For Covid, Isolated – dot newz

Published

on

By


Bengaluru:

Five contacts of an Omicron patient have turned out to be Covid positive, Karnataka announced today, shortly after the Union health ministry said the first patients of the new Covid variant have been found in the state. The patients have been isolated and their samples have been sent for genome testing, Karnataka said amid concern over the highly infectious strain that has set off global alarm.

One of the two initial patients is a 46-year-old health worker from Bengaluru, who developed symptoms of fever and body ache on November 21.

He tested positive the following day and was admitted to hospital; his sample was sent for genome sequencing on the same day.  But three days later he was discharged.

After extensive contact tracing, the Karnataka government said he had 13 direct contacts and more than 250 secondary contacts.

The other confirmed Omicron patient is a 66-year-old South African national who came to India with a negative Covid report.

The man, who received both vaccine doses, tested positive on arrival and was asymptomatic, following which he was told to self-isolate.

A week later, with a negative Covid report from a private lab, he flew to Dubai. Samples from his 24 primary and 240 secondary contacts have returned negative test results.



Source link

Continue Reading

Trending

Copyright © 2017 Dot Newz | Developed by MCVP Group 8